RecruitingGlioblastoma, IDH-wildtypeGlioblastomaGlioblastoma Multiforme

Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma or Astrocytoma

Eligible age

18+ yrs

Accepts

All genders

Locations

8 states

Healthy volunteers

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About this study

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

Sponsor: Orbus Therapeutics, Inc.

You may qualify if…

✓ Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A/B intact) per WHO 2021 tumor classification.
✓ Completed external beam radiation therapy per standard of care.
✓ Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.
✓ Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.
✓ Willing to abstain from intercourse or use acceptable contraceptive methods.
✓ If taking corticosteroids, must be on a stable or decreasing dose.

You may not qualify if…

✕ Recent history of recurrent or metastatic cancer that could confound response assessments
✕ Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).
✕ Prior Optune treatment.
✕ Active infection or serious intercurrent medical illness.
✕ Poorly controlled seizures.
✕ Significant cardiac disease within 6 months of enrollment.
✕ Poorly controlled diabetes.
✕ Use of another investigational agent within 30 days of enrollment.

Where it's recruiting

Birmingham

Detroit

Durham

Cleveland

Providence

Houston

Salt Lake City

Source: ClinicalTrials.gov · NCT05879367 · last updated 2025-06-25